MedFocus Clinical Study Manager in New York
Job Description: * Participate on a cross functional team focused on US regulatory submissions (FDA). * Previous Company experience is preferred; Pharmaceutical/biotech experience mandatory. * Work with alliance partners, coordination with third parties, to ensure inspection readiness, identify potential high risks for regulatory inspections. * Strong project management skills. Study management experience preferred but not required * Familiarity with U.S. NDA processes required
The Clinical Operations Study Team Lead (Study Team Lead) delivers on Company’s commitment to develop new medicines by leading internal (Dev Ops) and/or external (Alliance Partner/Vendor/Contractors) operational resources to ensure that overall study timeline, cost and quality goals are met. The Study Team Lead is an expert on the operational delivery of clinical trials and brings that expertise to the design and conduct of clinical development at Company. The Study Team Lead is accountable for the operational delivery of one or more clinical studies from study concept through reporting, submission and regulatory defense within one or more development projects. The Study Team Lead is responsible for operational oversight of all study activities and escalates issues when needed. The Study Team Lead provides joint leadership (in partnership with the Clinician) of the study team and ensures good team functioning. Serve in a leadership position for advancing architecture for a specific Line of Business, Enterprise Architecture Domain, or effort;
Provides Study Team Leadership –
Serves as co-lead (with Clinician) of study team and leads the Clinical Operations sub-team.
Ensures cross-functional connectivity among team members and supporting functional lines
Manages study team meetings and facilitates effective decision making
Fosters synergistic team health and engagement.
Supports Practical Clinical Trial Design
Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design.
Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed.
Facilitates early engagement of Alliance Partners/Vendors when needed.
Provides Operational Oversight – Accountable for the operational success of the study.
Serves as primary Dev Ops point of contact for the study. Engages early within project team to ensure effective up-front planning
Develops accurate study plans (timelines, budget) in concert with Alliance Partner/Outsourcing Provider and utilizing resources from Dev Ops Lines and aligning with RU/BU business needs.
Provides critical assessment of AP and 3rd party vendor proposals. Pressure tests planning and resourcing assumptions to ensure success.
Oversees Site Feasibility and Site Selection Process in partnership with CTSC (Named COL, Global Site Start Up Unit) and Alliance Partner/Vendor
Maintains collaborative working relationship with AP/CRO to provide appropriate level of AP/vendor oversight to ensure study success. Assists in issue resolution and escalation when needed.
Ensures and enhances investigator/site relationships.
Works proactively with AP/CRO and Company internal functions to ensure timely delivery of data.
Leads Quality/Risk Management Activities – Proactively identifies risks to delivery or quality and ensures that appropriate risk mitigation plans are in place.
Oversees the study risk planning process (e.g. IQMP)
Communicates opportunities and risks to the RU/BU and Dev Ops project leadership. Ensures cross functional buy-in to risk mitigation plans.
Ensures compliance with all applicable SOPs and Quality Standards
Raises quality issues when required.
Coordinates and oversees inspection readiness activities including maintenance of study documentation.
Provides Cross Company Coordination – Provides guidance on availability of expertise on Company processes and systems with access to Company subject matter experts to support AP/CRO tasks and issue resolution.
Provides Financial Oversight – Forecasts and manages high level clinical trial budget.
Cross functional team leadership
Regulatory submission experience preferred.
Oncology experience preferred.
Some travel may be required, but not definite
Regulatory submission experience
TOP FIVE CRITICAL SKILLS: Strong Project Management at least 3 to 5 years; Regulatory submission experience; Oncology experience; Bachelors Degree; Regulatory Submissions experience
Min Salary: $0.00
Max Salary: $0.00